An interventional study of ArcScan Insight 100 very high-frequency digital ultrasound and Carl Zeiss Meditec Cirrus HD OCT 5000 in Corneal Thickness Measurement, Epithelial Thickness Measurement and LASIK Flap Thickness Measurement, sponsored by London Vision Clinic. Suspended at 1 site in United Kingdom. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-26.
Sponsored by London Vision Clinic · Not applicable, Interventional, and Diagnostic
The purpose of this study is to evaluate the repeatability and reproducibility of corneal, epithelial, and LASIK flap thickness using the Carl Zeiss Meditec Cirrus HD OCT 5000, Optovue RTVue OCT, CSO MS-39 OCT, and ArcScan Insight 100 very high-frequency digital ultrasound arc-scanner.
Very high-frequency (VHF) digital ultrasound was first used in 1993 to obtain images and measure the thickness of the cornea (the window at the front of the eye) and the layers within the cornea, such as the epithelium (the layer of skin on the surface of the cornea). A commercially available instrument, known as the Artemis, has been used in routine clinical practice since 2001. The ArcScan Insight 100 VHF digital ultrasound scanner is an updated version, which obtained CE mark in 2016.
Optical coherence tomography (OCT) is another method of measuring the thickness of the cornea and the corneal epithelium. OCT has been used for measuring corneal thickness since 1997 and the technology had evolved to also measure epithelial thickness since 2012. There are currently three OCT scanners capable of measuring epithelial thickness; Carl Zeiss Meditec Cirrus HD OCT 5000, Optovue RTVue OCT, CSO MS-39 OCT.
The aim of the study is to establish the repeatability (i.e. the variability in measurements taken by a single examiner during a single visit) and reproducibility (i.e. the variability in measurements taken in the same conditions between two examiners) for each of the four devices for measuring corneal thickness and epithelial thickness.
London Vision Clinic is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Only patients who are medically suitable for corneal laser refractive surgery can be included in the study.
As general inclusion criteria the following aspects are defined:
For the normal eye populations:
For the post-op eye populations:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm will include 20 eyes of 20 patients with no previous ocular surgery. The research participant will be scanned a number of times using each of the four devices (the Insight 100 VHF digital ultrasound scanner, the Cirrus HD OCT 5000, the RTVue OCT, and the MS-39 OCT). The scan sequence will be undertaken on a single day as follows: 1. 5 consecutive repeated scans of the cornea will be performed by the first operator using each of the four devices (expected total time approximately 5 minutes for each OCT scan set and 15 minutes for the Insight 100 scan set). 2. There will be a break of about 30 minutes. 3. 5 consecutive repeated scans of the cornea will be performed by the second operator using each of the four devices (expected total time approximately 5 minutes for each OCT scan set and 15 minutes for the Insight 100 scan set).
Device: ArcScan Insight 100 very high-frequency digital ultrasound · Device: Carl Zeiss Meditec Cirrus HD OCT 5000 · Device: Optovue RTVue OCT · Device: CSO MS-39 OCT
This arm will include 20 eyes of 20 patients between 3 and 9 months after corneal laser refractive surgery. The research participant will be scanned a number of times using each of the four devices (the Insight 100 VHF digital ultrasound scanner, the Cirrus HD OCT 5000, the RTVue OCT, and the MS-39 OCT). The scan sequence will be undertaken on a single day as follows: 1. 5 consecutive repeated scans of the cornea will be performed by the first operator using each of the four devices (expected total time approximately 5 minutes for each OCT scan set and 15 minutes for the Insight 100 scan set). 2. There will be a break of about 30 minutes. 3. 5 consecutive repeated scans of the cornea will be performed by the second operator using each of the four devices (expected total time approximately 5 minutes for each OCT scan set and 15 minutes for the Insight 100 scan set).
Device: ArcScan Insight 100 very high-frequency digital ultrasound · Device: Carl Zeiss Meditec Cirrus HD OCT 5000 · Device: Optovue RTVue OCT · Device: CSO MS-39 OCT
This arm will include 101 eyes of 101 patients with no previous ocular surgery. The research participant will be scanned once using each of the four devices (the Insight 100 VHF digital ultrasound scanner, the Cirrus HD OCT 5000, the RTVue OCT, and the MS-39 OCT). Expected total time approximately 20 minutes to complete all four scans.
Device: ArcScan Insight 100 very high-frequency digital ultrasound · Device: Carl Zeiss Meditec Cirrus HD OCT 5000 · Device: Optovue RTVue OCT · Device: CSO MS-39 OCT
This arm will include 101 eyes of 101 patients between 3 and 9 months after corneal laser refractive surgery. The research participant will be scanned once using each of the four devices (the Insight 100 VHF digital ultrasound scanner, the Cirrus HD OCT 5000, the RTVue OCT, and the MS-39 OCT). Expected total time approximately 20 minutes to complete all four scans.
Device: ArcScan Insight 100 very high-frequency digital ultrasound · Device: Carl Zeiss Meditec Cirrus HD OCT 5000 · Device: Optovue RTVue OCT · Device: CSO MS-39 OCT
The ArcScan Insight 100 VHF digital ultrasound scanner can measure individual layers within the cornea with very high precision, as well as being able to image the interior of the eye including the chamber between the iris and the cornea, the lens and other structures behind the iris. The ArcScan Insight 100 device is a digital ultrasound scanner, meaning that it uses ultrasound waves to measure parameters of the eye. The Insight examination involves the patient sitting in front of the ultrasound unit and looking through a disposable goggle-like eyepiece at a light source. Warm sterile balanced saline solution (like natural tears) are used to fill the space between the light source and the eye, to allow ultrasound transmission. There is no contact between the instrument and the eye other than being immersed in this water bath.
Also known as: Artemis very high-frequency digital ultrasound
The Cirrus HD OCT 5000 uses high definition spectral domain optical coherence tomography (OCT) to measure anatomical structures of the eye. OCT is non-contact and uses light, rather than ultrasound, to obtain cross-sectional images. An OCT scan involves the patient sitting in front of the device, placing their chin on a chin-rest and fixating on a light source. Nothing comes into contact with the eye and the patient is only aware of the instrument rotating in front of them.
The Optovue RTVue OCT uses high definition Fourier/spectral domain optical coherence tomography (OCT) to measure anatomical structures of the eye. OCT is non-contact and uses light, rather than ultrasound, to obtain cross-sectional images. An OCT scan involves the patient sitting in front of the device, placing their chin on a chin-rest and fixating on a light source. Nothing comes into contact with the eye and the patient is only aware of the instrument rotating in front of them.
The CSO MS-39 OCT uses high definition Fourier domain optical coherence tomography (OCT) to measure anatomical structures of the eye. OCT is non-contact and uses light, rather than ultrasound, to obtain cross-sectional images. The MS-39 also includes a Placido topographer within the device to simultaneously obtain a measurement of the shape (curvature) of the front surface of the cornea, which is then combined with the OCT thickness measurement to generate the shape of the back surface of the cornea. An OCT scan involves the patient sitting in front of the device, placing their chin on a chin-rest and fixating on a light source. Nothing comes into contact with the eye and the patient is only aware of the instrument rotating in front of them.
Repeatability and reproducibility of Cirrus HD OCT 5000 corneal scans in normal eyes (standard deviation)
The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in normal eyes with no previous corneal surgery
Time frame: 10 minutes (5 minutes per observer)
Repeatability and reproducibility of RTVue OCT corneal scans in normal eyes (standard deviation)
The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in normal eyes with no previous corneal surgery
Time frame: 10 minutes (5 minutes per observer)
Repeatability and reproducibility of MS-39 OCT corneal scans in normal eyes (standard deviation)
The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in normal eyes with no previous corneal surgery
Time frame: 10 minutes (5 minutes per observer)
Repeatability and reproducibility of Insight 100 VHF digital ultrasound corneal scans in normal eyes (standard deviation)
The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in normal eyes with no previous corneal surgery
Time frame: 30 minutes (15 minutes per observer)
Repeatability and reproducibility of Cirrus HD OCT 5000 corneal scans in post-op eyes (standard deviation)
The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in eyes between 3 and 9 months after corneal laser refractive surgery
Time frame: 10 minutes (5 minutes per observer)
Repeatability and reproducibility of RTVue OCT corneal scans in post-op eyes (standard deviation)
The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in eyes between 3 and 9 months after corneal laser refractive surgery
Time frame: 10 minutes (5 minutes per observer)
Repeatability and reproducibility of MS-39 OCT corneal scans in post-op eyes (standard deviation)
The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in eyes between 3 and 9 months after corneal laser refractive surgery
Time frame: 10 minutes (5 minutes per observer)
Repeatability and reproducibility of Insight 100 VHF digital ultrasound corneal scans in post-op eyes (standard deviation)
The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in eyes between 3 and 9 months after corneal laser refractive surgery
Time frame: 30 minutes (15 minutes per observer)
Difference in corneal thickness measurements between Cirrus HD OCT 5000, RTVue OCT, MS-39 OCT, and Insight 100 VHF digital ultrasound in normal eyes
The difference between each pair of devices for measurements of corneal thickness and epithelial thickness in eyes with no previous ocular surgery.
Time frame: 20 minutes for all four scans
Difference in corneal thickness measurements between Cirrus HD OCT 5000, RTVue OCT, MS-39 OCT, and Insight 100 VHF digital ultrasound in post-op eyes
The difference between each pair of devices for corneal thickness, epithelial thickness and interface thickness in eyes between 3 and 9 months after corneal laser refractive surgery
Time frame: 20 minutes for all four scans
Plan to share: No — No data will be shared with other researchers
Start is estimated for Sep 2022; primary completion for Dec 2023, 15 months later.
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